UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of manual physical therapy for motor and life function
Title of the study (Brief title)	The effect of manual physical therapy
Region	Japan

Condition
Condition	Osteoarthritis of the knee and hip, low back pain, frozen shoulder
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of manual physical therapy for motor and life function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SF36, E-sas
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	manual physical therapy 16week 1-2 times a week 20-60 minutes/session
Interventions/Control_2	standard physical therapy 16week 1-2 times a week 20-60 minutes/session
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	patients with osteoarthritis of the knee or hip, low back pain, or frozen shoulder
Key exclusion criteria	Surgical operation before 6 months Rheumatoid arthritis Severe osteoporosis Uncontrolled hypertension Depression
Target sample size	400

Research contact person
Name of lead principal investigator	Daisuke Uritani
Organization	Japanese Physical Therapy Association
Division name	Manual physical therapy branch
Address	3-8-5 Sendagaya Shibuyaku Tokyo
TEL	03-5414-7911
Email	d.uritani@kio.ac.jp

Public contact
Name of contact person	Hideya Onoda
Organization	Japanese Physical Therapy Association
Division name	secretariat
Address	3-8-5 Sendagaya Shibuyaku Tokyo
TEL	03-5414-7911
Homepage URL
Email	onoda@japanpt.or.jp

Sponsor
Institute	Japanese Physical Therapy Association
Institute
Department

Funding Source
Organization	Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 14 Day
Anticipated trial start date	2016 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 14 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023743